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Brief Title: A Study of Ipatasertib (GDC-0068) in Combination With Paclitaxel as Neoadjuvant Treatment for Participants With Early Stage Triple Negative Breast Cancer
Official Title: A Phase II Randomized, Double-Blind, Study of Ipatasertib (GDC-0068), an Inhibitor to AKT, in Combination With Paclitaxel as Neoadjuvant Treatment for Patients With Early Stage Triple Negative Breast Cancer
Study ID: NCT02301988
Brief Summary: This is a randomized, double-blind, placebo-controlled, multicenter, pre-operative Phase II study designed to estimate the efficacy of ipatasertib combined with paclitaxel chemotherapy versus placebo combined with paclitaxel chemotherapy in women with Stage Ia - IIIa triple-negative breast adenocarcinoma. The anticipated time on study treatment is 12 weeks.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Arizona Oncology Associates, PC-CASA, Tucson, Arizona, United States
Sansum Medical Clinic, Inc., Santa Barbara, California, United States
Rocky Mountain Cancer Center - Lakewood (West), Lakewood, Colorado, United States
Massachusetts General Hospital, Boston, Massachusetts, United States
Mass General/North Shore Cancer, Danvers, Massachusetts, United States
Nebraska Cancer Specialists; Oncology Hematology West, PC, Omaha, Nebraska, United States
Carolinas Healthcare System, Charlotte, North Carolina, United States
Northwest Cancer Specialists - Portland (NE Hoyt St), Portland, Oregon, United States
Roper Bon Secours St. Francis Cancer Center, Charleston, South Carolina, United States
Texas Oncology, Austin, Texas, United States
Texas Oncology Cancer Center, Austin, Texas, United States
Texas Oncology - Baylor Charles A. Sammons Cancer Center, Dallas, Texas, United States
Texas Oncology - Houston (Gessner), Houston, Texas, United States
Texas Oncology-Tyler, Irving, Texas, United States
South Texas Cancer Center - McAllen, McAllen, Texas, United States
Northwest Medical Specialties, PLLC, Tacoma, Washington, United States
IPO de Lisboa; Servico de Oncologia Medica, Lisboa, , Portugal
Hospital Beatriz Angelo; Departamento de Oncologia, Loures, , Portugal
IPO do Porto; Servico de Oncologia Medica, Porto, , Portugal
Hospital Universitario Son Espases, Palma De Mallorca, Islas Baleares, Spain
Hospital Son Llatzer; Servicio de Oncologia, Palma de Mallorca, Islas Baleares, Spain
Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Oncologia, Santiago de Compostela, LA Coruña, Spain
Hospital Universitari de Lleida Arnau de Vilanova, Lleida, Lerida, Spain
Hospital Universitario Fundación Alcorcón, Alcorcón (Madrid), Madrid, Spain
Hospital Rey Juan Carlos; Pharmacy, Mostoles, Madrid, Spain
Hospital Regional Universitario Carlos Haya; hospital Materno Infantil, servicio de Farmacia, Málaga, Malaga, Spain
Hospital Universitario Virgen Macarena, Seville, Sevilla, Spain
Hospital Universitari Sant Joan de Reus; Servicio de Oncologia, Reus, Tarragona, Spain
Hospital Univ Vall d'Hebron; Servicio de Oncologia, Barcelona, , Spain
Institut Catala d Oncologia Hospital Duran i Reynals, Barcelona, , Spain
Hospital San Pedro De Alcantara; Servicio de Oncologia, Caceres, , Spain
Hospital Provincial de Castellon; Servicio de Oncologia, Castellon, , Spain
Hospital Universitari de Girona Dr. Josep Trueta; Servicio de Oncologia, Girona, , Spain
Centro Oncologico MD Anderson International Espana, Madrid, , Spain
Fundacion Jimenez Diaz; Servicio de Oncologia, Madrid, , Spain
Hospital Universitario Clínico San Carlos, Madrid, , Spain
Hospital Universitario 12 de Octubre; Servicio de Oncologia, Madrid, , Spain
Centro Integral Oncologico Clara Campal (CIOCC); Dirección Médica, Madrid, , Spain
Hospital Quiron de Madrid; Servicio de Oncologia, Madrid, , Spain
Hospital Universitario de Fuenlabrada; Servicio de Oncologia, Madrid, , Spain
Hospital Virgen del Rocio, Sevilla, , Spain
Hospital Clinico Universitario; Oncologia, Valencia, , Spain
Name: Clinical Trials
Affiliation: Genentech, Inc.
Role: STUDY_DIRECTOR